SURESIGN™ Digital Pregnancy Rapid Test

GUDID 50045611010029

3ct 25mIU - Digital Pregnancy Test

Guangzhou Decheng Biotechnology Co., LTD

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 50045611010029
• NIH Device Record Key: 71a0dea8-73e9-421c-ae69-d0cb8e58a91d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURESIGN™ Digital Pregnancy Rapid Test
• Version Model Number: 01002-4
• Company DUNS: 554534314
• Company Name: Guangzhou Decheng Biotechnology Co., LTD
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00045611010024 [Primary]
GS1	50045611010029 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222305

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-05
• Device Publish Date: 2026-01-28

Devices Manufactured by Guangzhou Decheng Biotechnology Co., LTD

• 30075450847636 - Hy-Vee® 6 Days Sooner/Early Detection Pregnancy Test: 2026-03-02 HyVee Pregnancy Test Early 3CT
• 00075450847642 - Hy-Vee® 6 Days Sooner/Early Detection Pregnancy Test: 2026-03-02 HyVee Pregnancy Test Early 2CT
• 00075450847659 - Hy-Vee® 6 Days Sooner/Early Detection Pregnancy Test: 2026-03-02 HyVee Pregnancy Test Early 1 CT
• 30075450847667 - Hy-Vee® Analog Pregnancy Rapid Test: 2026-03-02 HyVee Early Result Pregnancy Test 2 CT
• 30075450847674 - Hy-Vee® Digital Pregnancy Rapid Test: 2026-03-02 HyVee Pregnancy Test Digital 2CT
• 30075450847681 - Hy-Vee® Ovulation Kit: 2026-03-02 HyVee Ovulation Predictor 11CT
• 50045611010005 - SURESIGN™ Pregnancy Rapid Test: 2026-02-05 5ct 25mIU - Single Step Pregnancy Test
• 50045611010012 - SURESIGN™ Early Detection Pregnancy Test: 2026-02-05 5ct 10mIU - 6 Day Early Pregnancy Test